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Reforms in Biotechnology Sector

226 May 7, 2012

Minister of State for Planning, Science &Technology and Earth Sciences Dr Ashwani Kumar stated in Rajya Sabha today Govt. proposes to bring reforms in the regulatory framework in the bio-technology sector.

In reply to a question he said that currently research import, export, manufacture and use of all biotechnology products and processes involving genetically engineering are regulated through a elaborate food and environmental safety assessment under EPA Act 1986 (Rules 1989) administered under the Ministry of Environment and Forest. To professionalize the regulatory framework and address increasing complexity of safety assessment of biotech products, based on recommendations of expert committees, it is proposed to establish a Biotechnology Regulatory Authority of India (BRAI) through an act of Parliament. Accordingly, a BRAI Bill 2012 has been formulated and placed in the Parliament for introduction following official procedures and stakeholder consultations. The scope of the bull is to establish independent statutory regulator to regulate the research, transport, import, manufacture and use of organisms and products of modern biotechnology in terms of safety and efficacy. The commercial aspects of sale, licensing, price control and distribution of all products of modern biotechnology including agriculture and health care are out of the purview of the BRAI Bill and shall be dealt by the current policy and legislations in the Central and State Governments.

The Minister ruled out a fresh proposal to expand the scope and percentage of weighted deduction. Dr. Kumar clarified that as per the current tax incentives, a 200 per cent weighted deduction is available to firms that are engaged in biotechnology manufacturing or production. 100 per cent Tax free status for Biotech Special Economic Zones (SEZs) for 5 years is also provided. To supplement tax incentive and promote industrial R&D various public private partnerships schemes have also been launched. The Small Business Innovative Research Initiative (SBIRI) scheme of Department of Biotechnology to fund early stage research has benefited more than 89 small and medium biotech enterprises. Similarly, the Biotechnology Industry Partnership Programme (BIPP) launched recently, has so far benefited 51 companies undertaking research infuturistic high risk technologies.

The Minister revealed that during 2011-12, the biotechnology industry revenues reached Rs. 17,800 crores (US$ 4 billion mark at prevailing exchange rate) at a growth rate of 21 percent. The implementation of the various innovative schemes and their outputs, along with regulatory reforms, public private partnership schemes would help in sustaining and accelerating the pace of industrial R&D and manufacturing resulting production of affordable products of health care and agriculture, employment creation, import substitution and export promotion.